Cell therapy medical tourism: Time for action

Gunter, Kurt C.; Caplan, Arthur L.; Mason, Chris; Salzman, Rachel; Janssen, William E.; Nichols, Karen; Bouzas, Luis Fernando; Lanza, Francesco; Levine, Bruce L.; Rasko, John E.J.; Shimosaka, Akihiro; Horwitz, Edwin M.

doi:10.3109/14653249.2010.532663

Cited by 51 publications

(37 citation statements)

References 16 publications

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“…Implementing evidence-based guidelines alone implies that the patients' rights to choose a treatment that is safe are being denied. The ICST white paper 44 is in agreement with this and states that the patients may seek cellular therapies, which is their right and unless there is a high probability of causing harm to the patient such a treatment should not be withheld by the institution. However, the patients also have a right to information and accurate information about the safety, side effects and effectiveness of the treatment must be provided to the patients, prior to the therapy.…”

mentioning

confidence: 80%

“…The ICST "white paper" published in 2010 in Cytotherapy 44 gives clear guidelines for assessing the legitimacy and scientific rigor of the centers conducting stem cell research and offering stem cell therapy. There are three points highlighted in this paper for the consumers that serve to be a distinction between legitimate and fraudulent centers.…”

Section: Actionable Recommendationsmentioning

confidence: 99%

“…44 The white paper characterizes cellular therapy as medical innovation if it is provided by a qualified health care professional in their field of practice. Under circumstances when patients are not eligible for the controlled trials but are seeking the therapy, the researchers can offer the unproven therapy as a treatment option only after truthfully and ethically informing the patient about the nature of these therapies.…”

mentioning

confidence: 99%

“…Various centers offering cellular therapy should be distinguished, as given in the ICST white paper, 44 which states that the ICST guidelines should clearly divide and differentiate between: At present, most regulatory bodies only recognize: 1) approved/standard therapies (eg, hematopoietic stem cell transplant and other cellular therapies approved for marketing); and 2) controlled clinical trials. Anything apart from this is not recognized as ethical or legal.…”

mentioning

confidence: 99%

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Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Sharma¹,

AlZoubi²

2016

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Ethics, regulations, and evidence-based practices form the foundation of modern medicine. However, in recent years, and particularly in reference to cellular therapy, they have become obstacles to the growth and development of this new form of treatment. Based on four important documents, it is proposed that regulatory bodies and medical associations recommend an alternate way of looking at regulations for cell therapy, so as to ensure that only safe and effective treatments are offered to patients, and that greater availability of these new treatment options is also encouraged. The four documents on which these recommendations are based are: 1) World Medical Association Declaration of Helsinki -Ethical Principles for Medical Research Involving Human Subjects; 2) The International Society for Cellular Therapy "White paper" published in 2010; 3) The Beijing Declaration of the International Association of Neurorestoratology; and 4) New legislation passed in Japan in 2014 on regenerative medicine. These recommendations are: greater permissiveness for the use of cell therapy in incurable conditions, identify legitimate cell therapy services, promote medical innovation, respect the rights of patients to choose treatments, recognize the valid compassionate use of unapproved therapies, recognize the significance of small functional gains, give importance to practice-based evidence and existing published literature, have differing regulations for the different types of cell therapies, and adapt the new Japanese legislation for regenerative medicine.

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mentioning

confidence: 80%

Section: Actionable Recommendationsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Sharma¹,

AlZoubi²

2016

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“…These include sex change operations (Connell, 2006;Aizura, 2010), reproductive services and fertility treatment (Pennings, 2002;Blyth & Farrand, 2005), faith healing (Shankar, Paudel & Giri, 2006), unapproved procedures and medicine (Gray & Poland, 2008;Gunter et al 2010), organ transplants (Budiani-Saberi & Delmonico, 2008), assisted-suicide (Higginbotham, 2011) and other procedures.…”

Section: Literature Reviewmentioning

confidence: 99%

Sea, Sun, Sand and …. Selecting Surgery: an Exploration of Health, Medical and Wellness

Bristow¹,

Yang²

2015

hgeo

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Mass tourism facilities depend on repeat visitors as well as attracting new rst time tourists. As these traditional sun and sand holiday destinations mature, tourism promoters are bundling opportunities to attract a different kind of tourist. Since many of these resorts are all-inclusive facilities and include a Spa, one potential expansion may be to market to health, medical or wellness tourists. Geographic research in travel and tourism has found that individuals either repeat visits to the same destination or diversify their choices. This paper highlights the decision-making process of tourists and how it may be related to the niche market of health, wellness, and medical tourism. It uses data from a survey that gathered the travel patterns and motivations, and socio-demographics of medical tourists. Consumers who exhibit different travel behavior rank hospital accreditation and American hospital afliation more important than those who repeat travel behavior.

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Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

Bauer

Elsallab

Abou‐El‐Enein

2018

Stem Cells Translational Medicine

125

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The promise of stem cell (SC) therapies to restore functions of damaged tissues and organs brings enormous hope to patients, their families, loved ones, and caregivers. However, limits may exist for which indications SC therapies might be useful, efficacious, and safe. Applications of innovative therapies within regulatory boundaries and within the framework of controlled clinical trials are the norm in the scientific and medical community; such a system minimizes patient risk by setting a clear and acceptable safety and efficacy profile for new therapeutics before marketing authorization. This careful clinical validation approach often takes time, which patients suffering from terminal or debilitating diseases do not have. Not validated, unproven stem cell interventions (SCI) that promise a working treatment or cure for severe diseases have therefore found their way into the patient community, and providers of such treatments often take advantage of the public's willingness to pay large amounts of money for the misguided hope of a reliable recovery from their illnesses. We conducted a review of scientific publications, clinical case reports, and mass media publications to assess the reported cases and safety incidents associated with unproven SCI. The review also analyzes the main factors that were identified as contributing to the emergence and global rise of the “stem cell tourism” phenomenon. stem cells translational medicine 2018;1–10

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Cell therapy medical tourism: Time for action

Cited by 51 publications

References 16 publications

Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Rethinking on ethics and regulations in cell therapy as part of neurorestoratology

Sea, Sun, Sand and …. Selecting Surgery: an Exploration of Health, Medical and Wellness

Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions

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